U.S. patent application number 11/407239 was filed with the patent office on 2007-10-25 for composition and method for managing redness of skin associated with dermatological condition.
Invention is credited to Dana M. Watson.
Application Number | 20070248555 11/407239 |
Document ID | / |
Family ID | 38619676 |
Filed Date | 2007-10-25 |
United States Patent
Application |
20070248555 |
Kind Code |
A1 |
Watson; Dana M. |
October 25, 2007 |
Composition and method for managing redness of skin associated with
dermatological condition
Abstract
The present invention is directed towards a topical composition
for managing redness of skin associated with a dermatological
condition, comprising water, gelled ethyl alcohol (an
anti-bacterial), anti-oxidants, thickening agents, emulsifiers,
stabilizers, and a natural esterified anti-inflammatory (Hepes).
This combined therapy is more effective than anti-bacterial agents
alone and is particularly effective for those who do not respond
well to the solutions containing only anti-bacterial agents.
Inventors: |
Watson; Dana M.; (Raleigh,
NC) |
Correspondence
Address: |
H. JAY SPIEGEL - H. JAY SPIEGEL & ASSOCIATES
P.O. BOX 11
MOUNT VERNON
VA
22121
US
|
Family ID: |
38619676 |
Appl. No.: |
11/407239 |
Filed: |
April 20, 2006 |
Current U.S.
Class: |
424/70.13 ;
424/70.16; 424/70.31 |
Current CPC
Class: |
A61K 8/345 20130101;
A61K 8/4973 20130101; A61K 8/9794 20170801; A61Q 17/005 20130101;
A61K 8/34 20130101; A61K 8/8147 20130101; A61K 8/44 20130101; A61K
8/92 20130101; A61Q 19/00 20130101; A61K 8/8152 20130101; A61K
8/676 20130101; A61K 8/67 20130101 |
Class at
Publication: |
424/070.13 ;
424/070.16; 424/070.31 |
International
Class: |
A61K 8/81 20060101
A61K008/81; A61K 8/73 20060101 A61K008/73; A61K 8/37 20060101
A61K008/37 |
Claims
1. A topical composition for the managing of redness in skin
associated with dermatological conditions consisting essentially
of: a. Deionized Water present in an amount from about 25% to 70%
by weight of the composition; b. SD39C Alcohol present in an amount
from 2% to 60% by weight of the composition; c. Hepes Linoleate
present in an amount from about 0.5% to 20% by weight of the
composition; d. A moisturizer selected from the group consisting of
sodium pyrollidone carboxylate, glycerin, propylene glycol,
sorbitol, Caprylic/Capric Triglyceride, Aloe Vera gel and mixtures
thereof present in an amount from about 0.1% to 10% by weight of
the composition; e. An emulsifier selected from the group
consisting of PEG-12, Glyceryl Stearate SE, Glyceryl Stearate,
Isopropyl Myristate, Aluminum Hydroxide, xanthum gum, Carbopol 981
and mixtures thereof and present in an amount from about 0.1% to
20.0% by weight of the composition; f. Thickeners selected from the
group consisting of Bentonite, Cetyl Alcohol, Carbomer, Sorbitan
Oleate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, and mixtures
thereof and present in an amount from about 0.1% to 10.0% by weight
of the composition; g. Anti-oxidants selected from the group
consisting of Vitamin A (Retinyl Palmitate), Vitamin Tri-C
(Ascorbyl Palmitate, Sodium Ascorbyl Palmitate, &
Tetrahexyldecyl Ascorbate), Vitamin D3 (Cholecalcipherol), Vitamin
Bi-E (Tocopheryl Acetate & Tocopherol/D-Alpha Tocopherol),
Alpha Lipoic Acid, Coenzyme Q10, L-Selenothionine, Beta Glucan,
Evening Primrose Oil, Sodium Ascorbyl Phosphate, and mixtures
thereof present in an amount from about 0.1% to 15% by weight of
the composition; h. PH balancer selected as Potassium Hydroxide or
Sodium Hydroxide present in an amount from about 0.01% to 0.15% by
weight of the composition; i. Anti-microbials and Preservatives
selected from the group consisting of Sodium Benzoate, Potassium
Sorbate, Phenacetin, Methyl Paraben, Propylparaben, Phenoxyethanol,
Imidazolidinyl Urea, Tetrasodium EDTA and mixtures thereof and
present in an amount from about 0.05% to 10.0% by weight of the
composition.
2. The composition according to claim 1, wherein said SD39C alcohol
is present in an amount from about 2.0% to 60.0% by weight of the
composition.
3. The composition according to claim 1, wherein said water is
present in an amount from about 25% to 70.0% by weight of the
composition.
4. The composition according to claim 1, wherein said Hepes
Linoleate is present in the amount from about 1% to 10% by weight
of the composition.
5. The composition according to claim 1, wherein said moisturizer
is present as Aloe Vera and Capryylic/Capric triglyceride.
6. The composition according to claim 1, wherein said emulsifier is
present as Carbopol 981.
7. The composition according to claim 1, wherein said thickener is
a mixture of Sorbitan Oleate and Acrylates/C10-30 Alkyl Acrylate
Crosspolymer.
8. The composition according to claim 1, wherein said
anti-microbial and preservatives are Tetrasodium EDTA.
9. The composition according to claim 5, further acting as an
anti-inflammatory.
10. A method for treating a person afflicted with a chronic
inflammatory skin disorder that can develop in the third to sixth
decade of life characterized by four distinct clinical stages
predominately affecting the central aspect of the face which
comprises applying to an affected area of the person's skin in a
therapeutically effective amount of a composition consisting of: a.
Water b. SD39C Alcohol is present in an amount from about 2% to 60%
by weight of the composition; c. Hepes Linoleate is present in an
amount from about 0.5% to 20.0% by weight of the composition; d.
Moisturizers selected from the group consisting of sodium
pyrollidone carboxylate, glycerin, propylene glycol, sorbitol,
Caprylic/Capric Triglyceride, Aloe Vera gel and mixtures thereof
present in the amount from about 0.1% to 10% by weight of the
composition; e. Emulsifiers selected from the group PEG-12,
Glyceryl Stearate SE, Glyceryl Stearate, Isopropyl Myristate,
Aluminum Hydroxide, xanthum gum, Carbopol 981 and mixtures thereof
and present in the amount from about 0.1% to 20.0% by weight of the
composition; f. Thickeners selected from the group consisting of
Bentonite, Cetyl Alcohol, Carbomer, Sorbitan Oleate,
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, and mixtures thereof
and present in an amount from about 0.1% to 10.0% by weight of the
composition; g. Anti-microbials and Preservatives selected from the
group consisting of Sodium Benzoate, Potassium Sorbate, Phenacetin,
Methyl Paraben, Propylparaben, Phenoxyethanol, Imidazolidinyl Urea,
Tetrasodium EDTA and mixtures thereof and present in the amount
from about 0.05% to 10.0% by weight of the composition.
Description
BACKGROUND OF INVENTION
[0001] The present invention relates to the treatment of a
dermatological condition and, more specifically, to the treatment
of rosacea, by a topical application of a composition comprising a
combination of gelled ethyl alcohol and Hepes Linoleate. The
invention relates to topical compositions for the treatment of a
dermatological condition and, more specifically, to the treatment
of rosacea. The method for treatment preferably includes two to
three applications daily to the affected area of the skin.
[0002] Rosacea is a chronic inflammatory skin disorder that can
develop in the third to sixth decade of life characterized by four
distinct clinical stages predominately affecting the central aspect
of the face. The disease appears to be more prevalent in northern
climates where cold exposure is experienced more often, and in
light-skinned persons on whom flushing is common and sensitivity to
sunlight is particularly high. The first clinical evidence of
rosacea is frequent and causes intense vasodilation or flushing.
Most patients progress to a vascular stage characterized by display
of an erythema that can persist for hours or days after a
triggering event. Some patients remain stabilized at this stage
while some progress to an inflammatory stage characterized by
display of an array of papules and pustules in addition to the
persistent erytherma. This stage can become a chronic condition. A
few patients, mostly male, can progress to the final stage
characterized by a distinctive hyperplasia or swelling, especially
of the nose. Rosacea is a visible skin condition that can have a
high impact on the quality of life of the patient.
[0003] Successful management of rosacea begins with early diagnosis
and treatment. Treatment is generally aimed at controlling the
symptoms and making the skin look better. Currently there is no
cure for rosacea, though the frequency of its flare-ups can be
diminished and their severity reduced. Most cases of rosacea can be
controlled with anti-inflammatory medications combined with
avoiding lifestyle and environmental factors that may aggravate the
disorder in individual cases. Treatment generally works best at
improving the papules and pustules of rosacea; the redness of the
skin is more difficult to treat. There are two groups of
therapeutic agents for inflammatory rosacea conditions: (1)
systemic and topical antibiotics; and (2) retinoids. Systemic and
topical antibiotics include tetracycline, metronidazole,
erythromycin, minocycline, and clindamycin, but the use of these
agents is often accompanied by drug side effects, the development
of resistance, and changes in the normal microbial flora. Retinoids
include treinoin (vitamin A or retinoic acid), which is applied
topically to inhibit follicular keratinization, and isotretinoin
(13-cis-retinoic acid), which is administered systematically to
suppress the activity of the sebaceous glands. Retinoids are often
irritants and are not advised for individuals with sensitive skin.
Retinoids can also be phototoxic and they can induce thin and
easily bruisable, fragile skin.
[0004] Metronidazole (5-methyl-5nitroimidazole-1-ethanol), and
antibacterial, is currently one of the more frequently prescribed
treatments for rosacea in the United States. It is available as a
topical cream known as Metrogel..TM.. from Galderma. Metronidazole
is structurally similar to some materials which are believed to be
carcinogens and is, in fact, listed by the U.S. Environmental
Protection Agency as reasonably anticipated to be a human
carcinogen. See Merck Index, 1996, page 1051.
[0005] U.S. Pat. No. 5,972,993, Ptchelintsev, issued Oct. 26, 1999,
describes a method for treating rosacea and sensitive skin
conditions using certain specifically-defined antioxidants.
[0006] U.S. Pat. No. 5,952,372, McDaniel, issued Sep. 14, 1999,
describes a method for treating rosacea using oral or topically
applied ivermectin. This method of treatment is aimed at reducing
or eliminating the Demodex organisms which are frequently found on
the skin of rosacea patients.
[0007] U.S. Pat. No. 5,998,395, Klingman, issued Dec. 7, 1999,
describes a method for suppressing inflammation in an inflammatory
dermatosis, such as rosacea, using a topically applied composition
containing both a corticosteroid and a retinoid.
[0008] U.S. Pat. No. 6,028,118, Dupont et al., Feb. 22, 2000,
describes the use of shark cartilage extract as an anti-angiogenic,
anti-inflammatory and anti-collagenolytic material which may be
used in the treatment of rosacea.
[0009] U.S. Pat. No. 5,994,330, El Khoury, issued Nov. 30, 1999,
describes the treatment of acne and other inflammatory skin
conditions using topically administered muscarinic agents. The
therapeutic effects of the invention are said to include a decrease
in redness, swelling and inflammation.
[0010] U.S. Pat. No. 5,968,532, De Lacharriere, et al., issued Oct.
19, 1999, describes the use of an ethylene diamine derivative in a
cosmetic or dermatological composition containing a material having
an irritant side effect. The ethylene diamine derivative is said to
minimize skin irritation, erythema and sensations of inflammation
or rosacea stemming from the use of the cosmetic/dermatological
product.
[0011] U.S. Pat. No., 5,885,595, Corey, et al., issued Mar. 23,
1999, describes a cosmetic composition which includes a retinal
fatty acid ester. The composition is said to be effective for
treating chronoaging conditions of the skin and dermatological
disorders including acne, follicular and lesional papules, actinic
kertoses, oily skin and rosacea.
[0012] U.S. Pat. No. 6,071,541, Murad, issued Jun. 6, 2000,
describes the use of a topical composition which contains a hydroxy
acid or tannic acid to exfoliate a portion of the skin, stabilized
hydrogen peroxide to facilitate cleansing of the skin, and an
antimicrobial agent to inhibit or reduce microorganisms of the
skin. The composition is said to be effective in the treatment and
management of inflammatory skin conditions, such as acne and
acneiform rosacea.
[0013] U.S. Pat. No. 6,057,341, Charpentier, issued May 2, 2000,
describes pharmaceutical or cosmetic composition which include
novel bi-aromatic dibenzofuran derivatives. The compositions are
said to exhibit pharmacological responses of the retinoid agonist
type and are further said t be effective in treating keratinization
disorders, including acne rosacea.
[0014] U.S. Pat. No. 5,886,233, Steinmeyer, et al., issued Mar. 23,
1999, describes cyclohexanone derivatives used to synthesize
vitamin D compounds. The compounds are said to be useful for
treating skin, such as in the treatment of acne.
[0015] There remains a need in the art for a more effective and
otherwise improved methods for treating dermatological conditions
related to rosacea by, for example, topically applying
compositions, having a desired degree of effectivity, to areas of
the skin of a patient in need thereof.
SUMMARY OF INVENTION
[0016] According to the present invention, the chronic inflammatory
skin disorder, rosacea, can be controlled and cleared more
effectively than with the use of topical compositions in the prior
art by administering to the affected areas of the skin a
composition comprising water, gelled ethyl alcohol, thickening
agent, emulsifiers, moisturizers, stabilizers and a new chemical
entity that blocks the inflammatory cascade at the level of
phospholipase A.sub.2 (Hepes Linoleate). Specifically, the gelled
ethyl alcohol and the Hepes compound have a synergistic effect when
in a single formulation which leads to a more rapid clearing and is
notably effective in the treatment of rosacea and reducing the
redness in the skin. Typically rosacea can be controlled and
cleared by once or twice daily applications of a composition
comprising water, gelled ethyl alcohol, thickening agent,
emulsifiers, moisturizers, stabilizers and an anti-inflammatory
(Hepes Linoleate).
[0017] Thereafter, clearance can be maintained by less frequent and
or less potent applications of the composition.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0018] As noted above, in one embodiment, disclosed is a method for
treating rosacea of the skin of a patient by topically applying to
an area of the skin in need thereof, an effective amount of a
composition comprising gelled ethyl alcohol combined with the Hepes
compound. As used herein the word "treat," "treating" or
"treatment" refers to using the compositions of the present
invention therapeutically to ameliorate an existing condition
characterized by rosacea inflammatory skin conditions, and acne
vulgaris.
[0019] The present invention is based also in part on the use of a
non-steroidal, anti-inflammatory agent. This composition comprising
water, SD39C Alcohol, thickening agent, emulsifiers, stabilizers,
and an anti-inflammatory (Hepes linoleate) has a significant effect
on the reduction of swelling, relieving sensitivity and redness
associated with inflammatory acne conditions. Any inflammation that
occurs in the body is the end result of a series of events known as
the arachidonic acid cascade. The process starts with a traumatic
or chemical event that leads to injury of the cell membrane. Cell
membranes consist of phosolipids, which are complex lipid materials
that contain fatty acids, one of which is arachidonic acid. In the
initiation of the inflammatory process the first step is the
conversion of arachidonic acid into the specific mediators of
inflammation, which follows two pathways. One of the pathways is
called the cyclooxygenase pathway and the other is called the
lipoxygenase pathway. All anti-inflammatory agents block the
formation of the end products of these two pathways. Aspirin for
example blocks the cyclooxygenase pathway, while cortisone block
both pathways by interfering with the formation of arachidonic
acid. HO-1(Hepes linoleate) works in the same fashion, blocking
both pathways and interfering with the formation of arachidonic
acid and is the only non-steroidal compound known for blocking both
of these pathways. (Pugliese, et al., September 2000)
[0020] The topical compositions of the present invention include
water, an alcohol, an alpha hydroxy acid, a moisturizer, an
isosorbide and a detergent. The amount of water present in the
compositions of this invention may be from about 30 weight percent
to about 70 weight percent, based upon the weight of the
composition.
[0021] Preferably, the amount of water present is from about 35
weight percent to about 70 weight percent.
[0022] Organic peroxides which may be included in the topical
compositions of the present invention could include any
pharmaceutically acceptable organic peroxide, such as, for example,
benzoyl peroxide, lauroyl peroxide, and carbamide peroxide.
Preferably, the organic peroxide is benzoyl peroxide. The amount of
organic peroxide present in the compositions of the invention may
be from about 1 weight percent to about 20 weight percent, based
upon the weight of the composition. Preferably, the organic
peroxide is present in an amount from about 2.5 weight percent to
about 10 weight percent.
[0023] Alpha hydroxy acids which may be included in the topical
compositions of the present invention include any pharmaceutically
acceptable alpha hydroxy acid, such as, for example, glycolic acid,
lactic acid, 2-hydroxydecanoic acid, 2-hydroxystearic acid and
malic acid. Preferably, the alpha hydroxy acid is one that is
commonly used in topical compositions for treating acne, such as
glycolic acid or lactic acid. Most preferably, the alpha hydroxy
acid is glycolic acid. The amount of alpha hydroxy acid present in
the compositions of the invention may be from about 0.1 weight
percent to about 15 weight percent, based upon the weight of the
composition. Preferably, the alpha hydroxy acid is present in an
amount from about 1 weight percent to about 10 weight percent.
[0024] Moisturizers which may be included in the topical
compositions of the present invention include any pharmaceutically
acceptable moisturizer, such as, for example, sodium pyrollidone
carboxylate, glycerin, glycolic acid, propylene glycol and
sorbitol. Preferably, the moisturizer is sodium pyrollidone
carboxylate. The amount of moisturizer present in the compositions
of the invention may be from about 0.5 weight percent to about 20
weight percent, based upon the weight of the composition.
Preferably, the moisturizer is present in an amount from about 1
weight percent to about 10 weight percent.
[0025] Isosorbides which may be included in the topical
compositions of the present invention include any pharmaceutically
acceptable isosorbide. Such isosorbides include, for example,
dimethyl isosorbide, diethyl isosorbide, and ethylmethyl
isosorbide. Preferably, the isosorbide is an alkyl ester of
isosorbide, such as dimethyl isosorbide. The amount of isosorbide
present in the compositions of the invention may be from about 0.05
weight percent to about 20 weight percent, based upon the weight of
the composition. Preferably, the isosorbide is present in an amount
from about 0.05 weight percent to about 10 weight percent.
[0026] Detergents which may be included in the topical compositions
of the present invention include any pharmaceutically acceptable
detergent. Such detergents include, for example, sodium potassium
lauryl sulfate, cocamidopropyl betaine, sodium cocoylisethionate,
and disodium cocoamphopropionate. Preferably, the detergent is
sodium potassium lauryl sulfate or cocamidopropyl betaine. The
amount of detergent present in the compositions of the invention
may be from about 15 weight percent to about 60 weight percent,
based upon the weight of the composition. Preferably, the detergent
is present in an amount from about 25 weight percent to about 40
weight percent.
[0027] The compositions of the present invention also may contain
various other ingredients that are commonly included in topical
pharmaceutical compositions. Such ingredients include, for example,
thickeners, preservatives, binders, wetting agents, and bases.
[0028] Thickeners which may be included in the topical compositions
of the present invention include any pharmaceutically acceptable
thickener. Such thickeners include, for example, cetostearyl
alcohol, corn starch, polyethylene glycol, PEG-14M (PEG-14M is
available from Amerchol Corp., Edison, N.J.), xanthan gum, cetyl
alcohol, bentonite, carbomer, PEG 12, and magnesium aluminum
silicate. The thickeners may be present in the compositions of the
invention in an amount from about 1 weight percent to about 30
weight percent, based upon the weight of the composition.
Preferably, the thickener is present in an amount from about 2
weight percent to about 25 weight percent.
[0029] Preservatives which may be included in the topical
compositions of the present invention include any pharmaceutically
acceptable preservative. Such preservatives include, for example,
methylparaben, propylparaben, imidurea, Potassium Sorbate,
Phenacetin, and quatemium-15. Preferably, the preservative is
methylparaben or imidurea. The amount of preservatives present in
the compositions of the invention may be from about 0.05 weight
percent to about 1 weight percent, based upon the weight of the
composition. Preferably, the preservatives are present in an amount
from about 0.1 weight percent to about 0.7 weight percent.
[0030] Bases which may be included in the topical compositions of
the present invention include any pharmaceutically acceptable base.
Such bases include, for example, sodium hydroxide, sodium citrate,
sodium acetate, sodium phosphate, and sodium lactate.
[0031] Emollients which may be included in the topical compositions
of the present invention include any pharmaceutically acceptable
emollient. Such emollients include Glyceryl Stearate SE, Glyceryl
Stearate, Isopropyl Myrisate, and Aluminium Hydroxide. Preferably
the emollients are present in and amount from about 0.1 weight
percent to 0.7 weight percent.
[0032] The general therapeutic regimen or strategy using the
combination of the present invention preferably involves once to
twice daily applications, preferably twice daily, of the
combination to bring the acne under control. Thereafter, depending
on the characteristics of the condition it is possible to maintain
clearance by judicious application of the composition less
frequently and/or in lower concentrations.
[0033] Controlled studies on a significant number of patients have
shown the combined therapy according to the present invention is
not only additive, but may truly be synergistic. That is, the
combination is more effective than and produces responses not
obtained by the usual treatment regimens of a corticosteroid,
metronidazole, sulfacetamide, sulfur, and azelaic acid therapies
alone. Thus, Rosacea, the common chronic skin condition
characterized by a spectrum of clinical indications including
flushing episodes, erythema, telegiectasia, inflammatory
papulapustular eruptions resembling acne, and ocular symptoms clear
more rapidly with the combination. Moreover, relapses are delayed
and less severe. Significantly, improvement has been demonstrated
in conditions which have become refractory to standard of
conventional treatments.
[0034] It is important to note that Hepes is a compound that has a
taurine molecule as one of the major components. Taurine is an
important amino acid in the regulation of neurotransmitters, an
immune function and in the control of inflammation. Its
physiological mechanism is quite complex, but is known to inhibit
the lipoxygenase pathway in the arachidonic acid cascade. The
target leukotriene has been reported to be LTB4. Another reaction
is the regulation of intracellular calcium and the inhibition of
protein kinase C. These actions suggest that hepes is a significant
agent to reduce cellular inflammation and cellular proliferation.
(Pugliese, et al., September 2000) The key to this invention is the
use of a new molecule, a hepes ester, which makes a whole new
entity. All other applications in the literature that describe
hepes as an anti-inflammatory agent use a delivery system that is
by injection of venous infusion. Topical Hepes, Ehtane Sulphonic
Acid, (not Hepes Oleate) has been used topically for arthritis and
Rheumatis, as well as some applications for psoriasis, O'Sullivan
U.S. Pat. Nos. 4,544,656 and 4,753,942. These applications did not
include the ester.
[0035] In one application, a method of treating psoriasis and
similar related ailments comprised applying to an affected skin
area a therapeutically effective amount of at least one
skin-compatible zwitteronic aminosulfonic acid of the formula
wherein R is a straight or branched chain aliphatic radical, or RN
is substituted or unsubstituted nitrogen-containing heterocycle
which may have one additional hetero atom; and R' is a C.sub2-4
straight or branched chain alkylene radical, O'Sullivan U.S. Pat.
No. 4,544,656. In the second application, a method of treating
arthritis and rheumatism in human patients comprises the topical
application to an affected part of the patient's body of at least
one zwitteronic aminosulphonic acid. The acid is made up as a
pharmaceutical composition such as a cream and applied at a dosage
of 50 mu.g-50 mg of the acid per day for at least 5 days,
O'Sullivan U.S. Pat. No.4,753,942. It is notable that although
these applications are referring to skin conditions and
inflammatory conditions that neither of these inventions have
incorporated the esterified ester chain that is associated with the
hepes Oleate or Hepes Linoleate as used in the present
invention.
[0036] The present invention will now be described in more detail
with reference to the following specific, non-limiting examples. In
these cases the composition was extensively evaluated and unless
otherwise indicated the combination brought about rapid resolution
(control and clearing) within two-three days of twice daily
applications. The preferred ranges for the constituent ingredients
are as follows: TABLE-US-00001 SD39C Alcohol 2-60% Aloe Vera .1-10%
Caprylic/Capric Triglyceride .1-10% Hepes Linoleate .5-20% Evening
Primrose Oil .1-15% Carbopol 981 .12-1% Sodium Ascorbyl Phosphate
.1-15% Sorbitan Oleate .1-10% Tetrasodium EDTA .05-10%
Acrylates/C10-30 Alkyl Acrylate Crosspolymer .1-10% Vitamin D3
Cholecalcipherol .1-15% Peppermint Oil USP .1-10% Balance Deionized
Water Total 100% Composition
EXAMPLE 1
[0037] Using the Listed Concentrations of the Present Invention:
TABLE-US-00002 Deionized Water 48.60% SD39C Alcohol 35.00% Aloe
Vera 3.00% Caprylic/Capric Triglyceride 5.00% Hepes Linoleate 4.00%
Evening Primrose Oil 2.00% Carbopol 981 1.00% Sodium Ascorbyl
Phosphate 0.50% Sorbitan Oleate 0.30% Tetrasodium EDTA 0.20%
Acrylates/C10-30 Alkyl Acrylate Crosspolymer 0.20% Vitamin D3
Cholecalcipherol 0.10% Peppermint Oil USP 0.10%
[0038] Approximately 10 cases of dermatological conditions related
to rosacea were treated with the composition. In approximately 85%
of the group, the condition was brought under control within two to
three weeks of twice daily applications.
EXAMPLE 2
[0039] Using the Listed Concentrations of the Present Invention:
TABLE-US-00003 Deionized Water 64.60% SD39C Alcohol 10.00% Aloe
Vera 10.00% Caprylic/Capric Triglyceride 5.00% Hepes Linoleate
6.00% Evening Primrose Oil 2.00% Carbopol 981 1.00% Sodium Ascorbyl
Phosphate 0.50% Sorbitan Oleate 0.30% Tetrasodium EDTA 0.20%
Acrylates/C10-30 Alkyl Acrylate Crosspolymer 0.20% Vitamin D3
Cholecalcipherol 0.10% Peppermint Oil USP 0.10%
[0040] Approximately 15 cases of dermatological conditions related
to rosacea were treated with the composition. In approximately 70%
of the group, the condition was brought under control within two to
three weeks of twice daily applications.
EXAMPLE 3
[0041] TABLE-US-00004 Deionized Water 58.60% SD39C Alcohol 25.00%
Aloe Vera 5.00% Caprylic/Capric Triglyceride 5.00% Hepes Linoleate
2.00% Evening Primrose Oil 2.00% Carbopol 981 1.00% Sodium Ascorbyl
Phosphate 0.50% Sorbitan Oleate 0.30% Tetrasodium EDTA 0.20%
Acrylates/C10-30 Alkyl Acrylate Crosspolymer 0.20% Vitamin D3
Cholecalcipherol 0.10% Peppermint Oil USP 0.10%
[0042] Approximately 20 cases of dermatological conditions related
to rosacea were treated with the composition. In approximately 90%
of the group, the condition was brought under control within two to
three weeks of twice daily applications.
[0043] In these examples, the patients chosen ranged in ages from
25 to 55 years old and ranged in skin tones form very light to
medium complexions.
* * * * *